Expectations for data quality

Global footprint*

Lowcost

Metrics for meeting overall project timelines

Operational excellence

Prior positive experience with service provider

Project managerquality

Providerresponsiveness

Therapeuticexpertise

The most important attribute for sponsors to include a CRO on their preferred provider list across all research phases is Operational excellence. However, each attribute was indicated as a Top 5 driver for at least 20% of respondents in one or more phases.

Preferredproviderselectiondrivers

*Phase I respondents indicating the importance of Location of Phase I units in different global locations were coded into the Global footprint table.

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Top 5 driver for

of CRO respondents

Phase I CROPhase II/III CRO

Phase IV CROeTMF software

Small molecule (SM) API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

11%13%

16%

25%28%

28%

22%

20%

16%

33%

31%

34%30%30%

25%

25%

23%22%

5%

5%

7%

7%

11%

12%

12%6%

8%

11%

13%13%

15%

14%16%

15%

31%25%

23%

9%6%

2%

3%4%

11%

6%10%

11%8%

53%

Phase I CRO Phase II/III CRO

Phase IV CROeTMF software

SM API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

Phase I CROPhase II/III CRO

Phase IV CROeTMF software

SM API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

Phase I CROPhase II/III CRO

Phase IV CROeTMF software

SM API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

Phase I CROPhase II/III CRO

Phase IV CROeTMF software

SM API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

Phase I CROPhase II/III CRO

Phase IV CROeTMF software

SM API CMOSM drug product CMO

Biologic API CMOBiologic drug product CMO

0% 55%50%45%40%35%30%% of Respondents

25%20%15%10%5%

Number ofpreferredproviders

Respondents indicated their companies tend to have more preferred providers for manufacturing work, and fewer for outsourced technologies. About half of sponsors that have preferred providers for technology only have one provider on their list.

eTMF mean: 2.0

Num

ber o

f pre

ferr

ed p

rovi

ders

Phase IV mean: 3.2Phase II/III mean: 3.6Phase I mean: 3.7

Biologic API mean: 4.0Biologic drug product mean: 4.3SM drug product mean: 4.6SM API mean: 4.7

NON-LARGE: 29%

LARGE: 75%

OF SPONSORSOVERALL (n=296)

Phase II/IIICRO outsourcing

Phase ICRO outsourcing

NON-LARGE: 20%

LARGE : 68%

OF SPONSORS OVERALL (n=240)

Preferredprovideruse

About half of sponsors use preferred providers for outsourced clinical, manufacturing, or software work. However, there are differences in usage rates between large and non-large sponsors; large sponsors are more likely to use preferred providers.

NON-LARGE: 40%

LARGE: 60%

OF SPONSORSOVERALL (n=187)

Biologic drug productCMO outsourcing

NON-LARGE: 42%

LARGE: 55%

OF SPONSORSOVERALL (n=208)

Biologic APICMO outsourcing

NON-LARGE: 41%

LARGE: 59%

OF SPONSORSOVERALL (n=242)

SM drug productCMO outsourcing

NON-LARGE: 44%

LARGE: 62%

OF SPONSORSOVERALL (n=241)

Small molecule (SM)API CMO outsourcing

OF SPONSORSOVERALL (n=95)

eTMF softwareoutsourcing

NON-LARGE: 17%

LARGE: 53%

OF SPONSORSOVERALL (n=218)

Phase IV CRO outsourcing

Industry Standard Research takes a wide look at preferred provider arrangements with research, software, and manufacturing organizations by presenting data on preferred provider use, quantity, and selection drivers.